AI Captions. April 10. FDA II/III Study Hall

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 # FDA II Study Hall LIVE -- (10 Apr 2024) -- Gigaohm Biological High Resistance Low Noise Information Brief
 ## Streams
 - https://twitch.tv/videos/2116198929
 - https://stream.gigaohm.bio/videos/watch/qZvw7WKaSuUgA3hPAUXV8Z
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 WEBVTT
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 I think we're going to start again because my wife took the kids to the gym and I missed
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 the ride by about 30 seconds that's why actually the stream was still on and I was still doodling
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 because I was trying to figure out where the car went and then I think I just realized
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 that what happened was my wife took the kids to the gym which means that I can finish this
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 stream now as a second edition and then do something else after dinner to earn my bread.
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 So I'm going to go right away back to this and that means that I'll cut over here, I'll
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 put this one up, I'll get over to this one.
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 And I will head to the gym after this is over with and meet them after they're done shooting.
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 So they have this thing, you can look it up on the internet, it's called shoot 360 and
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 it's a little like workout place just for basketball and they get a half an hour of
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 shooting on like a rebounding machine and they also get like a half an hour of ball handling
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 and so they do that by themselves and then after that we play and so usually during that
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 hour I have a podcast in my ears or something like that and I'm shooting around on the big
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 gym. So it's a pretty nice place to go because it's also in this giant building that has
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 a full-size soccer field inside of it and so you just get this kind of very spacious
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 feeling, it's a giant gym with a giant place to shoot buckets and also it has soccer going
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 on and stuff so it's kind of like a little funny temple of sport. So that's where they
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 are now, I've got about 45 more minutes, I think that's all I need to finish this.
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 So I will escape out of here and we'll just let Uve continue to explain the subtleties
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 of getting an EUA from the FDA in February of 2020.
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 The guidance describes FDA's current thinking on this topic and should be reviewed as a
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 recommendation unless specific regulatory or statutory requirements are cited. The guidance
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 is applicable to all devices as defined under Section 201 of the Act. As you've seen earlier
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 in Dr. Tense's presentation, for the purpose of the guidance, real-world evidence is defined
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 as data relating to patient health status and or delivery of healthcare routinely collected
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 from a variety of sources. For example, real-world data include data derived from electronic
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 health records, claims and billing, data from products and disease registries and data gathered
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 from other sources such as mobile devices. For the purpose of the guidance, real-world
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 evidence is defined as a clinical evidence regarding the usage and potential benefit
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 or risk of a medical product derived from analysis of real-world data.
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 The regulatory context in which real-world evidence may be used, FDA will consider the use of real-world
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 evidence to support regulatory decision-making for merit devices when it concludes that the data
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 used to generate the evidence are sufficient quality to inform a supportive, support a particular
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 decision. Real-world data may potentially be used as some or all of the evidence necessary to
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 understand medical device performance at different points of the total product life cycle. For
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 example, real-world data may be used to generate hypothesis to be tested in appropriate clinical
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 study or be used as evidence for expanding the labeling or to include additional indications for
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 use. I would like to mention the guidance does not change FDA's standards for regulatory decision
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 making and in each context we will evaluate whether the available evidence is of sufficient
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 quality to address the specific. So I assume that he's going to be evaluating it when it comes to
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 EUAs that he himself has granted and that's where I think this regulatory scheme starts to become
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 incredibly sketchy because you might think that there might be an ACIP equivalent here but there
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 isn't there's just this one guy who they sheriff and a maybe a couple equivalents that are able to
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 give EUAs they make the decision and the context in which that decision could be made is solely
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 dependent on what he considers good and if it's all real-world data that he makes that decision on
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 all the better clinical studies can now be based on real-world data that includes data from medical
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 devices, mobile devices, disease registries and electronic health records. Do you see how a national
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 security priority could really streamline the use of an electronic health record to cross-reference
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 and verify a disease registry or cross-reference or verify mobile device data? Do you see where
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 a national security priority event could put a German-speaking American guy in front of you
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 telling you that he is the firewall between you and a wholly fraudulent set of diagnostics being
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 used to create the illusion of a pandemic? This is our firewall right here, this guy
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 and his angry presentation that he's being seems to be forced to being given right now. It's
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 extraordinary regulatory decision being made.
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 So what are the characteristics for real-world data to support particular regulatory decisions?
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 Please note that the FDA does not endorse one type of real-world data over another.
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 They're all the same. They're all great. Assess the reliability and relevance of the source
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 and the specific elements to determine whether real-world data sources and the proposed analysis
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 can generate evidence that is sufficiently robust to be used for a given regulatory purpose.
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 The primary factors FDA considers are assessing the reliability of data include data approval
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 that is how the data were collected and data assurance that is whether the people and processes
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 in place doing data collection and analysis provide adequate assurance that errors are minimized
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 and that the data quality and integrity are sufficient.
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 Real-world evidence might be used in support of regulatory decision-making in several situations
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 as listed here. For more detail in all of the
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 sections, I refer to section six of the guidance.
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 So before I end, I have two slides where I want to address a couple of questions,
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 common questions from sponsors which plan to transition an EUA IBD product to a full market
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 application. The first question is, can I use the analytical and clinical data obtained for an
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 EUA authorization? The answer is yes, if new modification to the device has been made since
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 the authorization. However, if modifications have been made, then the risk assessment of the
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 modification will be required to determine to which extent the changes to the device would
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 influence its performance. For clinical data, it's important to assure that the comparator
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 method used to determine the truth of the specimen is still viewed as an acceptable
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 preference method. And the second question, can I use generated the data outside of the US
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 for my FDA submission? The answer here is yes as well provided that the test procedure and
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 performance, the test procedure was performed according to the package insert with no deviations.
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 We encourage sponsors to contact early, as early in the development for questions
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 concerning the use of EUA data to support marketing submissions.
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 The last question, can real data be used to help support the advancement of EUIBD products
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 through full marketing status? As stated in the guidance, I just reviewed
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 under the right conditions, yes. Data derived from real-world sources
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 that potentially be used to support regulatory decisions. And under the right conditions,
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 real-world data and associated real-world evidence, they constitute valid scientific evidence
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 depending on the characteristics of the data. As I mentioned earlier several times,
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 we encourage sponsors to contact us early in the development for questions concerning data to support.
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 So data derived from real-world sources becomes validation. That's what we're doing here now.
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 We're allowing these EUA devices to be rolled out and then for them to collect their own data,
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 report their own results, call it real-world data and be a source of validation for a market
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 approval submission. And it's as simple as that. He's telling you exactly how it's done. Yes,
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 it can happen. This is the way it's done. This is where the reliability has to be feigned.
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 This is where these are the benchmarks that you need to meet. That's what he's saying.
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 It's extraordinary.
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 Marketing market applications. This is my last material slide.
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 I want to thank my division, the whole staff of my division of the Division of Microbiology
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 Devices. Everybody is one way or the other involved in EUAs. And I would like to especially
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 acknowledge the individuals listed here because they have performed the heavy lifting in most of
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 the EUAs that we have seen. All those thanks to OC and OCC for their continuous help as well as
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 to our colleagues from SIBO who have helped us with standards which you will develop.
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 These are the individuals who make EUA happen. They have stand up to any call of an emergency
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 and they have worked tirelessly over weekends to make these devices available to the public as
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 fast as possible. Thank you.
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 Tirelessly over the weekend.
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 And so that guy was essentially what he said was that he is the head of all the EUA because
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 this whole division of microbiology devices is EUAs, this whole department. So the division
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 of microbiology devices, isn't that an interesting division to be the head of for 20 years?
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 To get three houses for heading to not lose your accent?
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 Really wanted to thank everybody. It's good that we've got incredibly good time
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 for making out your critical positions, isn't it?
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 As a note to the Office of the Chief Scientist for actually being able to help facilitate a lot
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 of this work in the medical device innovation consortium where we could actually get a conference
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 together in very short time. So Frank Whitehold in particular has been in short time.
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 The ladies that started the conference said that they've been organizing this for months.
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 What is he talking about? Is that a short time to him?
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 Incredibly important in actually helping do a lot of the background work that is
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 helping facilitate hopefully the future for the collection of rural evidence.
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 And so to go on with Dr. Shur and Dr. Stenzel we're actually talking about
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 just let's drill down just a little bit more in the rural evidence and fundamentally
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 while he wants to drill down the real world evidence.
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 There was a 21st Century Cures initiative and we had the FDA reauthorization act
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 which led to Meduva for commitments actually to help get pre-imposed market information
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 to support regulatory decisions across the breadth of which.
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 That was a mention of something very important.
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 The 21st Century Cures initiative.
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 21st Century which led to Meduva for commitments actually to help get pre-imposed market information
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 to support regulatory decisions across the breadth of which it could pop.
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 A huge amount of real important legislation that underlies the possibility of pandemics.
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 Being executed in the way that they were executed this time is found in the 21st Century Cures
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 Act and initiative. And I strongly recommend that everybody look into that if you've never
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 heard of it before. I am a little bit less informed about this one that I am about prep
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 and about the National Vaccines Act but this one is essential and it's a part of this stepwise
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 move toward the prep act. And so I need to read into this as well but it's interesting
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 that he mentions that one as being pivotal.
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 Completely used. And underneath that the medical device innovation consortium has the
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 national evaluations system for health technology to help develop a space where real
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 evidence could actually fundamentally be used. Now in the Center for Devices and Real Logic Health
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 we actually have a strategic priority to do this and part of the strategic priority was
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 this guidance that that Uva just talked about which is a cross-center harmonized effort.
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 Now again you're probably going to see this many times throughout the day but
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 that context of collecting information from a real clean health care setting.
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 Obviously that information if it's going to be collected it's going to have to be analyzed to
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 be able to be used in the context of valid scientific evidence. Now what are we talking about?
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 In the traditional setting you know obviously many of you are familiar with the fact that
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 studies are designed and they're conducted and analyzed. And then when those devices go out to
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 market I please note the context here that an ID is probably not necessary in every single
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 situation. In some cases it might be and I would refer to the Rural Evidence Guidance
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 to actually provide the context for that but when those devices actually get to market
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 or get to actual use in a health care setting they begin to help generate data.
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 Then that data when it's generated is done in a natural health care setting and then the question
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 is how can we collect and analyze that information so it can actually be useful. And so this is an
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 unprecedented shift in the way we think about medical records and medical data and they are
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 shifting it at a very opportune time right before the pandemic starts when we're going to grant 200
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 plus EUAs for diagnostics that could actually be the data collection that could be reflected back
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 on the nationwide electronic medical records etc. They are talking about a national
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 security priority here right this is a national security priority and so all of this talk about
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 what to do with the data and how to collect it has built into it these national security priorities
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 which may actually lead to them doing things that they wouldn't otherwise do collecting data that
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 they wouldn't otherwise do and interfacing with electronic medical records in a way that they
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 wouldn't otherwise do in order to facilitate a national security priority of moving more EUA products
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 to full market approval I can't write worth a damn when I'm actually talking while I write and
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 trying to write what I'm saying because then I try to write too fast so what does this say moving
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 more EUA products to full market approval I should write that without so such scribble scratch here
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 but that's the national security priority that has been ascribed to the entire seminar
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 I'm so glad I got to close this out with a little bit of a of a closer here because it's really
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 this is really summarizing the last three the last three so well as we looked at this seminar from
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 February 3rd 2020 what we are seeing is that the national security priority is not the safe and
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 effective products that are rolled out but it is getting more EUA products to successfully get
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 to full market approval using this shift from having to go through a pre-market submission system
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 to being able to use real world evidence gathered during the EUA stage to get through the approval
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 process without having to go through all this pre-market submission stuff
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 replacing what was required in a pre-market submission as outlined by Louvay sheriff that includes things like
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 that includes quality control that includes precision that and now can instead be substituted
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 within silico evaluation and no full validation is required and and that means that all of these
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 things can in theory get through with real world evidence that has been misconstrued as validating
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 their effectiveness and that is a very dangerous place to be had February 3rd 2020 February 3rd
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 it hasn't even started yet and we're already throwing all regulatory systems out of the out of the
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 out of the window and having a german national with a thick accent explained to us how we can
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 circumvent the traditional methods of pre-market approval before full market approval of the FDA
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 by getting an EUA and doing everything with real world data that can even include things as mundane
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 mobile device data never mind data from other EUA products right which could also be used to
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 evaluate whether or not the virus was there and so then one EUA product is validating the
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 effectiveness of another EUA product don't you see it holy cow it's amazing in that space
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 fundamentally we need data quality data quality is a very important key yeah it's all processed
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 data quality understand what the information is inside of a health care system exactly how
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 are you going to be able to use it now this question is the common question
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 that really drives the next statement of what is valid scientific it's fundamentally so per
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 our regulations you can submit anything you want to but fundamentally we can only rely on
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 valid scientific evidence and to be a little more clear about what valid scientific evidence could
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 be it really is a very broad breadth and range um well controlled investigation parcel controlled
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 studies objective trials and even reports of significant human experience if it can actually
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 be determined that you know by qualified experts that there's reasonable assurance
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 of safety and effectiveness that are real world personal experience can also be used to evaluate
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 the effectiveness of an FDA device here he just said those words you want to hear him say him again
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 I'll roll it back half a second now information
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 objective trials and even reports of significant human experience if it can actually be determined
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 that you know by qualified experts that's impressive there's reasonable assurance
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 to say from the fact that information that's impressive that's impressive and has been used
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 support regulatory decisions it doesn't always follow the traditional space but certainly
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 it's noted that things that are weird really can't be used as valid scientific evidence is it's not
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 logical a rationality section kind of be taken into place so what is not regarded as valid
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 scientific evidence is your isolated case reports are random experiences um if you don't have enough
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 detail around it how do you actually use utilize that information this is where the key comes in
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 so all we care about the end of the day is information that's fit for purpose and the appropriate
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 yes he did of a particular setting so we're talking he did he said weird things we don't use
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 weird things weird things are not generally scientific but you know it's a individual evaluation
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 basis talking about information that's relevant and reliable we have to be able to make a determination
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 fundamentally that the benefits outweigh the risks and that we can actually utilize that
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 information and throwing in a little extra complexity into that setting of course is that we try to
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 make sure that patients information is properly protected so we have harmonization for that
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 information it does become a little more understandable at how you can actually navigate patient
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 protection information and get high quality information out so in the rural evidence space
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 now he's using very big words to describe how they are going to try to protect people's personal
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 data while using it to evaluate EUA devices I don't think you can hear it any other way he
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 used the phrase here at the bottom information harmonization do you know what that is that's got
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 to be the the interface between an electronic medical record database and the database of a
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 pharmaceutical company the database of a social media company interfacing with the data from a
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 electronic medical medical record database would be information harmonization and talking about
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 how to anonymize make all anonymous the data or to protect people's personal data
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 is precisely what you would talk about if you intended to use a national security priority
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 to allow people to create information harmonization when that would no way shape or form be allowed
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 under the normal laws governing medical data and its use
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 that's why he has to use these big words and talk with such obfuscating sentences because
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 he doesn't tell you want everyone to understand it does become a little more understandable
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 at how you can actually navigate patient protection information and get high quality
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 information out so in the rural evidence space the HIPAA privacy role is how we operate for
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 helping protect that information and the understanding that not everything in the research space is
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 covered under under HIPAA that the access and use for the common role helps provide a little
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 additional context there but that being said information in the rural setting has been used
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 in many different spaces there for indication expansion for new indications for condition of
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 approval in both a pre-market and post-market setting and all these slides will be available
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 online if you want to do a deep dive but there has certainly been information collected from
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 multiple different venues and the point is please be creative and don't limit yourself
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 to that information. The perfect example which I think may have a degree of applicability
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 in this setting in particular is the note of an ability to actually utilize a publicly maintained
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 database when we actually partner together what was able to happen here in the next
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 chance sequencey space and I think that something that could be replicated in an EUA space next
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 gen sequencing appropriately set up is in lieu of full traditional studies what we're able to use
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 is information directly harvested from a publicly retained a publicly maintained database because
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 there was collaboration that happened up front between the sponsors between the database folders
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 and between FDA and when we actually partner together to get interoperability for that data
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 and establish appropriate quality checks which are achievable it was achievable in this case
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 and it'll be achievable in the future we can actually work together if you have questions
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 about real-world evidence there is actually an email address if you don't want to contact
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 the divisions directly you can you can email c3h clinical evidence at fda.h just.gov and if you
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 want to learn more about some of the public private partnerships you can contact c3h clinical
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 evidence at fda.h just.gov or if you want to learn more about shield in the diagnostic space you can
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 contact me thank you so thank you to all of the fda colleagues for sharing the fda perspective
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 today I think it sets a wonderful foundation for our discussions today and I look forward to
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 your engagement throughout the day as well we're going to take a break now and I'm going to make
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 a deal with you you guys silence your phones I'm hearing some phones and I promise we'll work
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 on getting those technology smoothing up here how's that for a deal wow so they're done that
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 was the end of that one and that's fine I knew it was not the much left because I didn't want to
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 leave it till after practice and then have to do that so we are still here ladies and gentlemen
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 at the same place where we have been for a very long time
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 oh I didn't mean to do that I apologize
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 you like that thing though I don't think it's that bad it actually looks pretty good that's also
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 render forest you know render forest is kind of fun so that was the last part of the market seminar
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 we won't do that one anymore I've taken my notes I've got my stuff I've got a lot more work to do
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 on Uve Sheriffs patents and some of the country companies that he worked for and we're going to
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 look at I'm going to look at some of his publications and try to decide if it's possible that maybe he
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 was doing more than just giving out EUAs maybe he was involved in the Human Genome Project or
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 in collaboration with companies that were involved in the Human Genome Project and
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 that might give us a clue to why he was in charge of giving away diagnostic EUAs
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 and and why it would be that EUAs would be given away by single people or by some weird
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 division called microbiome microbiological devices which is a very bizarre thing
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 so thanks for coming back for the last half hour if you missed it live thanks for coming back and
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 checking it out I will try to be on later this evening and later this evening I've got at least
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 a list of 20 or so things that I could cover and so we'll just see which of these pending
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 sort of study halls that is necessary to do that I'll do at eight o'clock and I'll see you then
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 thanks very much for coming and we'll be back soon
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 # FDA III Study Hall LIVE -- (10 Apr 2024) -- Gigaohm Biological High Resistance Low Noise Information Brief
 ## Streams
 - https://twitch.tv/videos/2116298320
 - https://stream.gigaohm.bio/w/wUwkuujnTJyMYDLMBYcTMy